ISO 24166-3:2022

INTERNATIONAL ISO
STANDARD 24166-3
First edition
2022-08
Snap-on bottles for metering pumps —
Part 3:
Plastic
Flacons encliquetables pour pompes doseuses —
Partie 3: Plastique
Reference number
© ISO 2022
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 3
5 Dimensions .4
5.1 General . 4
5.2 Bottles without sealing ring . 4
5.3 Bottles with sealing ring . 5
6 Materials . 7
7 Requirements . 7
7.1 General requirements . 7
7.2 Physical requirements . 8
7.2.1 Vertical Force . . . 8
7.2.2 Particulate contaminations . 8
7.3 Chemical requirements . . 8
7.4 Sterilization . 8
8 Marking of the bottle .8
9 Packaging options . 8
9.1 General packaging requirements . 8
9.2 Packaging for nonsterile plastic bottles . 9
9.3 Ready to sterilize or sterile plastic bottles . 9
Annex A (informative) Snap-on considerations .10
Annex B (informative) Tightness test .12
Annex C (informative) Inner depth measuring .13
Annex D (informative) Vertical force measurement technical method .14
Annex E (informative) Example of a packaging configuration .17
Bibliography .18
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
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iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
A list of all parts in the ISO 24166 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
This document is part of a series of International Standards for containers made from different
materials used in combination with metering pumps for medicinal applications.
Glass containers are mainly used for that purpose. Plastic containers can be used as an alternative.
This document can be used for the development of standardized filling and assembling equipment.
Based on the dimensions of the containers, appropriate components, such as metering pumps and other
closure systems can be developed and standardized. As such this document provides important inputs
for developing entire packaging systems for medicinal applications.
Primary packaging materials are an integral part of medicinal products. Thus, depending on the
jurisdiction, the principles of the current Good Manufacturing Practices (cGMP) can apply to the
manufacturing of these components (e.g. ISO 15378).
v
INTERNATIONAL STANDARD ISO 24166-3:2022(E)
Snap-on bottles for metering pumps —
Part 3:
Plastic
1 Scope
This document specifies the shape, dimensions, fill capacities and performance requirements of plastic
bottles for metering pumps. It also specifies the material for the manufacturing of such containers as
well as the secondary packaging.
The document provides requirements for packaging of the plastic bottles and addresses nonsterile,
ready to sterilize or sterile as three possible options.
This document is applicable to colourless or coloured containers moulded from plastic and intended to
be used in the packaging, storage or transportation of products intended for medicinal use.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
base foil
packaging component for protection of the pallet load from contamination
3.2
bottle
vial
container made of a suitable material, which is intended for packaging, storage and application of liquid
medicinal products
EXAMPLE Tubular glass, moulded glass or plastic.
3.3
brimful capacity
volume of water required to fill a container, placed on a flat, horizontal surface
[SOURCE: ISO 4802-1:2016, 3.3]
3.4
chemical indicator
test system that reveals change in one or more pre-defined process variables based on a chemical
change resulting from exposure to a process
[SOURCE: ISO 11139: 2018, 3.43, modified — "pre-specified" was replaced with "pre-defined", "or
physical" was deleted.]
3.5
customer
business entity that purchases bottles for metering pumps and conducts further processing or filling as
appropriate
[SOURCE: ISO 21882:2019, 3.1 modified — “sterilized ready for filling vials” was replaced with “bottles
for metering pumps”.]
3.6
dip-tube
conduit, part of the metering pump, which delivers the product from the bottle to the metering
mechanism
3.7
foil bag
gas permeable or non-permeable bag
Note 1 to entry: Foil bags can be used as sterile barrier system (3.17) or as protective packaging (3.13), depending
on final usage.
3.8
label
written, printed or graphic information appearing on the item itself, on the packaging of each item or
on the packaging of multiple items
[SOURCE: IMDRF/GRRP WG/N52: 2019, 3.17, modified – replaced "unit" and "devices" with "item"]
3.9
manufacturer
business entity that manufactures or is otherwise responsible for the manufacturing of the bottles
ready to be filled by the customer (3.4)
[SOURCE: ISO 21882:2019, 3.14 modified – “performs” was replaced with “manufactures”, “vials” was
replaced with “bottles”.]
3.10
metering pump
device actuated by the user to deliver a specific dose of liquid
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
pallet
construction for transportation and storage of goods
3.13
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.14
sealing ring
bottle feature on top of the flange to support tightness
3.15
shipper box
protective packaging for the foil bags
3.16
snap-on bottle
container with press-fit for metering pumps
3.17
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.18
transport
...